Associate Director/Director Facilities and Engineering

Associate Director/Director Facilities and Engineering

Santa Monica, CA

Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the paradigm of treatment for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.

We are seeking a highly motivated individual for the role of Associate Director or Director of Facilities and Engineering (F&E), depending on experience, to work in an exciting new area of cell therapy at Neogene Therapeutics. This role reports directly to the Head of Global Manufacturing.

Responsibilities include, but are not limited to:

  • Leads the day-to-day activities of the F&E function
  • Responsible for selection of vendors, execution of work orders by vendors and acts as primary point of contact for facility operation and services at US locations
  • Develops, implements, and maintains a fit for purpose Asset Lifecycle Management System for GMP and non-GMP assets across all facilities
  • Develops, implements, and maintains a fit for purpose Calibration/Maintenance Program for non-GMP and GMP Assets across all facilities
  • Responsible for oversight and direction for capital projects to ensure schedules and budgets are maintained.
  • Develops, reviews, modifies, and implements F&E policies and procedures.
  • Provides oversight and support for F&E programs to ensure Safety, GMP and Environmental Compliance
  • Defines and oversees execution of commissioning and qualification plan for existing equipment systems
  • Develops equipment and system specifications, procures, installs, and oversees execution of commissioning and qualification of new equipment and systems

Requirements:

  • Minimum required education/experience for BS + 12 years, for MS +10 years or for PhD + 8 years.
  • At least 8 years of pharmaceutical or biotech industry experience in increasing levels of responsibility and operational excellence or Lean manufacturing principles
  • Minimum of 8 years of people management experience
  • Develops solutions to problems of moderate complexity, which require a high degree of ingenuity, creativity, and innovativeness.
  • Demonstrates active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced, dynamic, and highly fluid company environment with minimal direction and able to adjust workload based upon changing priorities
  • Up to 10% travel required
  • Advanced Engineering Degree highly desired.
  • Project Management certification or equivalent is a plus
  • Knowledgeable with cGxP as well as regulatory regulations and compliance requirements for cell therapy and pharmaceutical industry
  • Able to express ideas and present information effectively to leadership, within team functions, and with external partners
  • Ability to think critically with demonstrated troubleshooting and analytical skills

We offer the opportunity to join a highly dynamic growth-stage biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.